Clinical Trial: Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients

Brief Summary: This study will evaluate the effectiveness of ketamine infusions in the management of acute pain resulting from broken ribs suffered following a blunt trauma. Half of patients will receive the institutional standard of care and a placebo infusion (no active medication). The other half of patients will receive the institutional standard of care and a ketamine infusion. All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.

Detailed Summary:

A prospective randomized, double blinded trial of ketamine use in adult and elderly blunt trauma patients with associated rib fractures admitted to the trauma service will be conducted. Examples of blunt mechanisms include assault, falls, motor vehicle collisions, motorcycle crashes, motor vehicle pedestrian collisions, crush injuries, and bicycle accidents. The experimental arm of the trial will receive ketamine infusion therapy while the control arm receives saline placebo infusions at an equivalent rate. All patients will be managed with adjunct therapy including opiates in accordance with the institutional thoracic trauma protocols. This trial will focus on adult blunt trauma patients who have associated rib fractures. The focus on adult rib fracture patients stems from an injury pattern in which there is a high incidence of prolonged opiate utilization and development of chronic pain. Elderly rib fracture patients are certainly of interest and this trial will evaluate the benefits of ketamine infusions in this population as a distinct entity given the discrete differences in the complications of rib fractures and the goals of therapy.

All blunt trauma patients with associated rib fractures will be screened. All patients will be enrolled into the institutional standard thoracic trauma pathway. All individuals will undergo Intercostal Nerve Block (ICNB) in the Emergency Department or on admission to the Intensive Care Unit. In addition to scheduled medications per institutional thoracic trauma protocols, all patients will receive adjunct opiate therapy. Patients will be screened by the clinical and pharmacy staff following the diagnosis of rib fractures for eligibility. Patients enrolled into the trial will be randomized into either the experimental or control arm of the trial. The Investigational Drug Services (IDS) department will randomize all enrollees and handle a
Sponsor: Medical College of Wisconsin

Current Primary Outcome: AUCpain [ Time Frame: 12-24 hours post infusion ]

Primary outcome will be the area under curve for the pain trajectory (AUCpain) during the 12 - 24 hours after initiation of pain treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • AUCpain [ Time Frame: 6-12 hours post infusion ]
  • AUCpain [ Time Frame: 2-6 hours post infusion ]
  • AUCpain [ Time Frame: 24-48 hours post infusion ]
  • ICU Length of Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5-7 days. ]
    Participants will be followed from time of admission to time of discharge. The average hospital length of stay is expected to be 5-7 days.
  • Length of Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5-7 days. ]
    Participants will be followed from time of admission to time of discharge. The average hospital length of stay is expected to be 5-7 days.
  • Opiate Utilization [ Time Frame: 1st 24 hours post infusion ]
    Standardized to morphine equivalents
  • Opiate Utilization [ Time Frame: 1st 48 hours post infusion ]
    Standardized to morphine equivalents
  • Opiate Utilization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5-7 days. ]
    Participants will be followed from time of admission to time of discharge. The average hospital length of stay is expected to be 5-7 days.
  • Opiate Side Effect Frequency [ Time Frame: Duration of Infusion (expected average duration of infusion is 4 days) ]
    Nausea, Emesis, Pruritus, Sedation
  • Regional Anesthesia Utilization [ Time Frame: 1st 48 hours ]
    Epidural, Intercostal Nerve Blocks
  • Regional Anesthesia Utilization [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5-7 days. ]
    Epidural, Intercostal Nerve Blocks. Participants will be followed from time of admission to time of discharge. The average hospital length of stay is expected to be 5-7 days.
  • Rib Fracture Complication Frequency [ Time Frame: Admission up to 3 months post-discharge ]
    Including Pneumonia, Oxygen Dependency, Need for Non-Invasive Ventilation, Intubation. Participants will be followed from time of admission to time of discharge. The average hospital length of stay is expected to be 5-7 days.
  • Development of Chronic Pain [ Time Frame: Admission up through 3-4 months post discharge ]
    Chronic pain will be defined based on responses to the brief pain index - short form evaluation completed by patients.


Original Secondary Outcome: Same as current

Information By: Medical College of Wisconsin

Dates:
Date Received: April 20, 2015
Date Started: September 2015
Date Completion: August 2017
Last Updated: February 12, 2017
Last Verified: February 2017